Senior Manager, Regulatory Affairs

Summit Therapeutics; Abingdon; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Manager of Regulatory Affairs to oversee regulatory activities for various projects. The role involves preparing submissions, managing clinical studies, and ensuring compliance with regulations. Ideal candidates will have extensive experience in regulatory affairs and strong communication skills, contributing to strategic planning and execution of regulatory submissions.

Qualifications

• 3+ years in Regulatory Affairs.
• 7+ years in pharmaceutical, biotechnology, or life sciences.

Responsibilities

• Manage clinical trial applications and European-focused MAA pre-submission activities.
• Provide regulatory guidance and update teams on activities.
• Collaborate with cross-functional teams for regulatory documents.

Skills

Communication

Interpersonal Skills

Detail-oriented

Education

BA/BS in Biological or Health-related Sciences

Master's, PhD, or PharmD

Tools

MS Office

Electronic Document Management Systems

Job description

*Position will be on-site. Relocation support will be considered for this role.

Overview of Role:

Reporting to the European Regulatory Director, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These projects include preparing and compiling submissions for regulatory agencies, managing clinical studies, overseeing regulatory submission processes and timelines, and maintaining regulatory tracking tools, archives, and infrastructure.

The role is primarily home-based out of: UK, Ireland, Germany, Belgium, Netherlands, Switzerland

Role and Responsibilities:

1. Own projects and activities, including clinical trial applications (CTAs) and other European-focused MAA pre-submission activities.
2. Contribute to and drive the regulatory content and strategy for marketing authorization submissions and pre-MAA submissions.
3. Provide regulatory guidance internally on study-team decisions.
4. Update study/project teams on regulatory activities during team meetings.
5. Manage and track queries, commitments, and submissions with regulatory agencies; collaborate with subject matter experts to provide responses as needed; and provide periodic status updates on unfulfilled conditions or commitments.
6. Collaborate with cross-functional study teams to plan regulatory documents, including health authority meetings such as scientific advice, paediatric, and orphan designation.
7. Contribute to or lead internal meetings such as kick-off meetings and cross-functional project updates.
8. Manage and support internal document processes, including review, finalization, sign-off, and archiving.
9. Support global and regional regulatory submissions and strategic planning as applicable.
10. Contribute to and monitor regulatory compliance before and after approval.
11. Perform all other duties as assigned.

Experience, Education, and Skills:

• BA/BS degree in biological or health-related sciences required; Master's, PhD, or PharmD preferred.
• Minimum 3+ years of experience in Regulatory Affairs.
• Minimum 7+ years of experience in the pharmaceutical, biotechnology, or life sciences industry.
• Knowledge of EMA and European guidance, regulations, drug development process, and industry practices.
• Strong written and oral communication skills.
• Proven interpersonal skills and experience working cross-functionally.
• Detail-oriented with the ability to work proactively, organize, prioritize, and delegate tasks.
• Experience interacting with CROs, including CTA and clinical trial activation experience preferred.
• Experience with EU/European health authority systems such as IRIS and CTIS is desirable.
• Proficient in MS Office (Word, PowerPoint, Excel); experience with electronic document management systems and review tools is desirable.